ME-344 is a novel mitochondrial inhibitor targeting energy production through the OXPHOS pathway, which is important for supporting tumor cell survival and proliferation for many forms of cancer, including colorectal cancer.
Bevacizumab, a vascular endothelial growth factor (VEGF) inhibitor, and other antiangiogenics, increase reliance on mitochondrial energy production, thereby providing an opportunity to evaluate a combination with a mitochondrial inhibitor like ME-344 to inhibit energy production in tumor cells and induce an antitumor effect.
Dr Howard Hochster, professor and director, GI Oncology, Rutgers Cancer Institute, said: “As one of the most commonly diagnosed cancers, and a leading cause of cancer-related deaths in both men and women in the United States, there is a high medical need for new therapies to treat colorectal cancer, particularly for patients who have failed standard therapy and have metastatic disease."
“This clinical study presents an important opportunity to evaluate a novel approach to treatment with the potential to bring improved benefit to patients. This target is quite unlike other treatments for colorectal cancer, and will be studied by investigators at the Rutgers Cancer Institute Metabolomics Center of Excellence in conjunction with the trial. We are excited to join with our colleagues nationally in the Academic GI Cancer Consortium (AGICC) to investigate this promising agent.”
Richard Ghalie, chief medical officer of MEI Pharma, added: “We are excited to continue to pioneer the evaluation of mitochondrial inhibition as a promising approach to treat solid tumors with the initiation of this innovative study evaluating ME-344, our mitochondrial inhibitor, in combination with bevacizumab in patients with colorectal cancer who progressed after standard therapies.”
“With the current study, we look forward to the opportunity to build on both mechanistic and efficacy data from earlier pre-clinical and clinical studies demonstrating the anti-tumor activity of ME-344 in combination with bevacizumab.”
The company anticipates announcing safety and efficacy data from the first cohort of 20 ME-344 patients in the first half of 2024.
